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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697213
Other study ID # 18/0253
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 25, 2019
Est. completion date March 1, 2020

Study information

Verified date March 2020
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the use of the Surprise Question [SQ] (would you be surprised if this patient were to die in the next 12 months?) in routine practice. In particular, the study will investigate the consistency of the responses to the SQ and the relationship with the subsequent course of action decided upon.


Description:

Whilst the original use of the Surprise Question was to identify people who might be in the last year of life and benefit from palliative care, the prognostic capability of the Surprise Question has been shown to be variable. What is unclear, is the extent to which a doctor should be "surprised" before a patient is suitable for palliative care, how consistently doctors respond to this question, and how the subsequent treatment decision relates to the SQ response.

The study will recruit 600 General Practitioners (GPs) from 6 participating countries (100 per country; UK, Germany, Switzerland, Italy, Belgium, the Netherlands). Each participant will asked to complete a series of 20 hypothetical patient summaries in an online task.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Registered General Practitioner in one of the six participating countries

- Able to read and understand the language in which the questionnaire is presented to them

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online study
20 hypothetical patient summaries

Locations

Country Name City State
Belgium University of Antwerp Antwerp
Germany University of Mainz Mainz
Italy University of Bologna Bologna
Netherlands Radboud University Medical Centre Nijmegen
Switzerland University Hospital of Bern Bern
United Kingdom Marie Curie Palliative Care Research Department London

Sponsors (7)

Lead Sponsor Collaborator
University College, London Imperial College London, Johannes Gutenberg University Mainz, Radboud University, Universiteit Antwerpen, University of Bern, University of Bologna

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Probability estimate The continuous estimate of probability of dying within the next 12 months for the SQ (0-100%). Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20)
Secondary The Surprise Question Dichotomous response to the SQ (Yes/No) up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)
Secondary The alternative Surprise Question Dichotomous response to the alternative SQ (Yes/No) up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)
Secondary Treatment options The options for the course of action selected by the participants in each vignette up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)
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